Latest News in the pharma Industry

Policy & Regulation

FDA grants Orphan Drug Designation for True North Therapeutics' lead product candidate, TNT009

FDA grants Orphan Drug Designation for True North Therapeutics' lead product candidate, TNT009

13 Oct 2016

TNT009 is currently in clinical development for the treatment of autoimmune hemolytic anemia, including Cold Agglutinin Disease (CAD), a form of autoimmune hemolytic anemia.

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Arch Biopartners receives patent for Metablok

Arch Biopartners receives patent for Metablok

11 Oct 2016

Is the first patent issued protecting the composition and method of use for Metablok, the company's drug candidate targeting inflammation, sepsis and cancer metastasis.

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FDA accepts sNDA for Avycaz

FDA accepts sNDA for Avycaz

11 Oct 2016

Application seeks to expand Avycaz label to include Phase III clinical data for the treatment of complicated urinary tract infections.

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FDA approvs infant-specific dose of Pertzye delayed-release capsules to treat EPI due to cystic fibrosis

FDA approvs infant-specific dose of Pertzye delayed-release capsules to treat EPI due to cystic fibrosis

11 Oct 2016

The new formulation will be offered in 4,000 lipase units capsule.

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Patent trial and appeal board upholds the validity of Lialda patent

Patent trial and appeal board upholds the validity of Lialda patent

6 Oct 2016

Shire pleased with the decision and will continue to vigorously defend its patents.

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Theratechnologies to move forward with development of new single vial formulation for Egrifta

Theratechnologies to move forward with development of new single vial formulation for Egrifta

28 Sep 2016

The introduction of a single vial presentation was part of commitments required by the FDA when it approved Egrifta (Tesamorelin for Injection).

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Biogen completes rolling submission of NDA to FDA for nusinersen as a treatment for spinal muscular atrophy

Biogen completes rolling submission of NDA to FDA for nusinersen as a treatment for spinal muscular atrophy

27 Sep 2016

Submission of Marketing Authorization Application to the EMA planned in the coming weeks.

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FDA approves Amgen's new biosimilar for multiple inflammatory diseases

FDA approves Amgen's new biosimilar for multiple inflammatory diseases

25 Sep 2016

Amjevita is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases.

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Novartis receives three new FDA approvals for the expanded use of Ilaris

Novartis receives three new FDA approvals for the expanded use of Ilaris

23 Sep 2016

Ilaris is the first and only US FDA-approved biologic treatment for patients with TRAPS, HIDS/MKD and FMF disease.

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FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

FDA issues draft guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

22 Sep 2016

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EMA validates BMS’s type II variation application for Opdivo in advanced form of bladder cancer

EMA validates BMS’s type II variation application for Opdivo in advanced form of bladder cancer

20 Sep 2016

Extends the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.

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FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

FDA grants accelerated approval to first drug for Duchenne muscular dystrophy

19 Sep 2016

Approval given to EXONDYS 51 (eteplirsen) as a once weekly intravenous infusion of 30 mg/kg for the treatment of DMD in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping.

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